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A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02057380
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date September 3, 2018
Actual Study Start Date  ICMJE April 16, 2014
Actual Primary Completion Date October 14, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Number of subjects with adverse events [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02057380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
Official Title  ICMJE A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
Brief Summary The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: linsitinib
    oral
    Other Name: OSI-906
  • Drug: erlotinib
    oral
    Other Names:
    • OSI-774
    • Tarceva
  • Drug: paclitaxel
    Intravenous (IV) infusion
  • Drug: Bortezomib
    Subcutaneous or IV
    Other Name: Velcade
  • Drug: Dexamethasone
    IV, Oral
    Other Names:
    • Maxidex
    • Baycadron
    • Ozurdex
    • Decadron
Study Arms  ICMJE
  • Experimental: Arm A: High dose linsitinib twice daily monotherapy
    Arm A includes subjects from Protocol OSI-906-301
    Intervention: Drug: linsitinib
  • Experimental: Arm B: High dose linsitinib BID plus high dose erlotinib QD
    Arm B includes subjects from Protocol OSI-906-205
    Interventions:
    • Drug: linsitinib
    • Drug: erlotinib
  • Experimental: Arm C: High dose erlotinib monotherapy once daily
    Arm C includes subjects from Protocol OSI-906-205 and OSI-906-207
    Intervention: Drug: erlotinib
  • Experimental: Arm D: High dose linsitinib BID plus weekly paclitaxel
    Arm D includes subjects from Protocol OSI-906-202
    Interventions:
    • Drug: linsitinib
    • Drug: paclitaxel
  • Experimental: Arm E: Highest dose linsitinib intermittent once daily
    Arm E includes subjects from Protocol OSI-906-202, linsitinib on Days 1-3 of each week plus weekly paclitaxel
    Interventions:
    • Drug: linsitinib
    • Drug: paclitaxel
  • Experimental: Arm F: Paclitaxel alone weekly
    Arm F includes subjects from Protocol OSI-906-202
    Intervention: Drug: paclitaxel
  • Experimental: Arm G: Lowest dose linsitinib twice daily + low dose erlotinib
    Arm G includes subjects from Protocol OSI-906-103
    Interventions:
    • Drug: linsitinib
    • Drug: erlotinib
  • Experimental: Arm H: high dose linsitinib twice daily
    includes subjects from protocols SARC 022/CTEP 8945, linsitinib x28 days (each cycle)
    Intervention: Drug: linsitinib
  • Experimental: Arm I: highest dose linsitinib once daily
    includes subjects from EuroSARC protocol, linsitinib on Days 1-3; Days 8-10 and Days 15-17
    Intervention: Drug: linsitinib
  • Experimental: Arm J: Low dose linsitinib 2x daily+bortezomib & dexamethasone
    includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
    Interventions:
    • Drug: linsitinib
    • Drug: Bortezomib
    • Drug: Dexamethasone
  • Experimental: Arm K: med. dose linsitinib 2x daily+bortezomib&dexamethasone
    includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
    Interventions:
    • Drug: linsitinib
    • Drug: Bortezomib
    • Drug: Dexamethasone
  • Experimental: Arm L: high dose linsitinib 2x daily+bortezomib&dexamethasone
    includes subjects from protocol MM-001; Days 1, 4, 8 & 11 (cycles 1-8) and Days 1, 8, 15 & 22 (cycles 9+)
    Interventions:
    • Drug: linsitinib
    • Drug: Bortezomib
    • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2014)
60
Actual Study Completion Date  ICMJE December 21, 2016
Actual Primary Completion Date October 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis.
  • Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating.
  • Subject must be deriving benefit from continued treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Czechia,   Germany,   Poland,   Singapore,   Thailand,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02057380
Other Study ID Numbers  ICMJE 7487-CL-0209
2013-004076-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP